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Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia

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ClinicalTrials.gov Identifier: NCT03305354
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Edith Nourse Rogers Memorial Veterans Hospital
Information provided by (Responsible Party):
Karen Quigley, Northeastern University

Brief Summary:
Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans) have notable sleep problems including chronic insomnia. Here, the investigators plan to compare two groups of veterans with insomnia: (1) one group that completes a 6 week self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will have better subjective and objective sleep, higher step counts, and better functional health and social and community integration than those receiving CBTI alone. This pilot work will provide evidence to guide the design of a future randomized controlled trial.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Behavioral: CBTI app intervention Behavioral: Physical Activity intervention Not Applicable

Detailed Description:
To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep, physical activity, functioning, or social engagement over and above self-management use of a CBTI app alone, the investigators will randomly assign post-9/11 veteran participants with chronic, functionally impairing insomnia to either (1) a self-management-based use of an app based on cognitive behavioral therapy for insomnia (CBTI; CBTI alone arm) or to (2) a self-management-based use of the CBTI app + a physical activity (PA) intervention (CBTI + PA) that includes PA monitoring (via a Fitbit device) with individualized goal-setting to encourage increased daily steps across the 6 weeks. For the PA goal, the investigators will attempt to get all participants to at least the typical 10,000 daily steps goal cited as a strong predictor of positive health outcomes (Choi, Pak, & Choi, 2007). The investigators will tailor the step goals based on the person's initial level of daily steps, and increment step goals weekly to maximize motivation and enhance the likelihood that the participant can meet the goal.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia: Does Enhancing Physical Activity Help?
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBTI app intervention
Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide
Behavioral: CBTI app intervention
Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep

Active Comparator: CBTI app+Physical Activity Intervention
Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts
Behavioral: CBTI app intervention
Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep

Behavioral: Physical Activity intervention
Self-management guided motivation to increase physical activity by increasing daily step counts




Primary Outcome Measures :
  1. Insomnia Severity Index Total Score [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Total score on the Insomnia Severity Index

  2. Pittsburgh Sleep Quality Index Total Score [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Total score on the Pittsburgh Sleep Quality Index Total Score


Secondary Outcome Measures :
  1. Objective Sleep Efficiency [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor

  2. Daily step counts [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Daily step counts as measured by a Fitbit device


Other Outcome Measures:
  1. Functional Outcomes of Sleep [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Functional Outcomes of Sleep Questionnaire total score (10 item version)

  2. Social Engagement [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Total score on the Lubben Social Network Scale

  3. Community Engagement [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Total score on the Community Integration Questionnaire

  4. Physical Functional Health [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Physical Function score from the Veteran's RAND-12 scale

  5. Mental Functional Health [ Time Frame: 6 weeks (Immediate post-intervention) ]
    Mental Function score from the Veteran's RAND-12 scale



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible individuals will be US military Veterans
  • Eligible veterans will have served in the military during the post-9/11 period
  • Eligible veterans will have chronic, functionally impairing insomnia (i.e., at baseline veterans must have an Insomnia Severity Index score > 10 with insomnia duration of at least 1 month, and impaired daytime functioning.
  • Eligible individuals must be willing to use devices (e.g., Fitbit, WatchPAT)provided by the study team.
  • Eligible individuals may have mild or moderate obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] <= 30 events/hour of sleep).

Exclusion Criteria:

  • Periodic leg movements
  • Circadian rhythm disorder
  • Use of medications or health issues (e.g., permanent pacemaker, sustained non-sinus cardiac arrhythmias, finger deformity, etc.) that would interfere with the use of the WatchPAT sleep monitor
  • Severe obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index [AHI] > 30 events/hour of sleep)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305354


Contacts
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Contact: Karen S Quigley, PhD 617-373-3794 k.quigley@northeastern.edu
Contact: Erin D. Reilly, PhD 781-687-4191 erin.reilly@va.gov

Locations
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United States, Massachusetts
Edith Nourse Rogers Memorial VA Hospital Recruiting
Bedford, Massachusetts, United States, 01730
Contact: Erin D. Reilly, PhD    781-687-4191    Erin.Reilly@va.gov   
Contact: BethAnn Petrakis, MA    781-687-2975    BethAnn.Petrakis@va.gov   
Sponsors and Collaborators
Northeastern University
Edith Nourse Rogers Memorial Veterans Hospital
Investigators
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Principal Investigator: Karen S Quigley, PhD Northeastern University

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Responsible Party: Karen Quigley, Research Associate Professor, Northeastern University
ClinicalTrials.gov Identifier: NCT03305354     History of Changes
Other Study ID Numbers: 17-09-10
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Karen Quigley, Northeastern University:
mobile health
physical activity

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders